Guidelines for industrial radiation sterilization of disposable medical products (Cobalt-60 gamma irradiation)

This IAEA document is aimed at providing necessary guidance on standards and criteria and assistance to Member States, particularly developing countries, in their attempts to properly set up facilities for industrial radiation sterilization of duly-manufactured medical products by exposure to Co-60 gamma radiation. The contents of the guidelines have therefore been designed, as far as practicable, to reflect the practices and procedures currently employed in the processing of the majority of the radiation-sterilized medical products being produced worldwide. Consequently, this document has attempted to present to its users, for information and for action, all the relevant features of the standard criteria as are currently in existence under the auspices of the various authoritative national and/or regional Codes or Guides. The potential user(s) from Member States are expected to freely decide which of the various standards as enumerated in the Guidelines document should be considered for inclusion or exclusion either partially or totally in the context of the formulation of their own nationally-acceptable guidelines. Refs and tabs